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Cancer Genetics, Inc. Announces Pricing of Public Offering of Common Stock

On January 9, 2019 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported the pricing of an underwritten public offering of 13,333,334 shares of its common stock at a price to the public of $0.225 per share (Press release, BioServe Biotechnologies, JAN 9, 2019, View Source [SID1234532612]). Cancer Genetics also granted the underwriter a 45-day option to purchase up to an additional 2,000,000 shares of its common stock at the public offering price of $0.225 per share, less underwriting discounts and commissions. Cancer Genetics expects to receive aggregate gross proceeds of approximately $3.0 million from the offering, assuming no exercise of the underwriter’s option to purchase additional shares. The offering is expected to close on or about January 14, 2019, subject to customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

Cancer Genetics intends to use the net proceeds from the offering to pay lender fees and other costs incurred in connection with the potential forbearance agreements it is negotiating with its banks, to pay certain costs previously incurred by it in connection with its terminated transaction with NovellusDx Ltd., and if any proceeds remain available, to fund working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 5, 2017. A preliminary prospectus supplement describing the terms of the offering was filed with the SEC on January 9, 2019, and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

OncBioMune Announces Former Puma Biotechnology Executive and Genentech Veteran Brian Barnett, M.D., as Chief Executive Officer

On January 9, 2019 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy and targeted cancer therapies, reported that its Board of Directors has appointed Brian Barnett, M.D., as Chief Executive Officer (Press release, Oncbiomune, JAN 9, 2019, View Source [SID1234532611]).

Prior to joining the Company, Dr. Barnett served at Puma Biotechnology, Inc. since August 2016 ("Puma") most recently as a Vice President and Head of Medical Affairs. Prior to his time with Puma, Dr. Barnett was with Genentech, Inc., a subsidiary of Roche, from October 2012 to August 2016 and served as Medical Director, Kadcyla (T-DM1), Global Product Development Oncology and U.S. Medical Affairs. Prior to his appointment as CEO, Dr. Barnett was a member of the Company’s Scientific Advisory Board. Dr. Barnett received his B.S. from Millsaps College, M.D. from the University of Mississippi Medical Center, and completed his Medical Oncology Fellowship at Tulane University in New Orleans.

Dr. Barnett succeeds Dr. Jonathan Head as Chief Executive Officer at OncBioMune. Dr. Head will continue to serve the Company as the Chairman of the Board of Directors and now as its Chief Scientific Officer.

"It has long been our strategy to advance ProscaVax into mid-stage clinical trials for prostate cancer and find my successor from big pharma to lead our continued growth and pipeline development," commented Dr. Head. "Dr. Barnett was a natural choice given his experience at Puma and Genentech and understanding of our pipeline through his time as an advisor to the Company. I am confident that the Company is going to benefit from Dr. Barnett’s passion for drug development, business savvy and industry connections and I am thrilled to introduce him as our new CEO."

"I am excited and honored to take this opportunity to lead OncBioMune and spearhead development of our pipeline of exceptional drug candidates," said Dr. Barnett. "As an oncologist and as I’ve gotten to know the company more intimately, I see the opportunities that are presented with ProscaVax, the platform vaccine technology and our patented targeted transferrin transport technology. As we move forward with the Phase 2 trials of ProscaVax, I intend to focus on and expedite development of the transferrin technology simultaneously. This is an underappreciated part of our pipeline that I believe can possibly help cancer patients by addressing an unmet need and will resonate potentially as a tumor-agnostic, biomarker-directed and targeted approach to cancer therapy."

As previously announced, OncBioMune intended to host a shareholder call in December. With change in leadership, the company is rescheduling the call for later this quarter to give Dr. Barnett some time to get acclimated to his new position.

Athenex Announces Completion of Target Enrollment in the Oraxol Phase III Study

On January 9, 2019 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that target enrollment of 360 patients in the Oraxol Phase III clinical trial in metastatic breast cancer has been achieved on schedule (Press release, Athenex, JAN 9, 2019, View Source;p=RssLanding&cat=news&id=2382773 [SID1234532606]). Athenex also reaffirms that top line data from the study is expected to be available in mid-2019.

About Oraxol Phase III Study

Oraxol is an innovative oral formulation of paclitaxel, a very effective and commonly used anti-cancer chemotherapy, combined with HM30181A (a novel gastrointestinal tract specific P-glycoprotein pump inhibitor). The Oraxol Phase III study is an open-label, randomized, multicenter study to determine the safety, tolerability, and tumor response of Oraxol compared with IV paclitaxel in patients with metastatic breast cancer, with a target enrollment of 360 adult female patients. Secondary endpoints will measure progression-free survival and overall survival. More information about this study is available at www.clinicaltrials.gov.

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi

Halozyme Provides 2019 Pipeline Update And Financial Guidance At 37th Annual JP Morgan Healthcare Conference

On January 9, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported its 2019 financial guidance at the 37th annual JP Morgan Healthcare Conference (Press release, Halozyme, JAN 9, 2019, View Source [SID1234532605]).

"Looking ahead, our ENHANZE business is gaining momentum with key product development milestones expected this year, including potential FDA approval of a subcutaneous formulation of Herceptin and regulatory submissions for the subcutaneous formulation of Darzalex each representing important near-term catalysts," said Dr. Helen Torley, president and chief executive officer. "In our oncology business, HALO-301 has completed enrollment and topline results are projected in the second half of 2019."

Halozyme provided an update on the 2019 outlook for its ENHANZE franchise. The company expects to make meaningful progress this year toward its projection of the potential for approximately $1 billion in royalty revenue in 2027. During the first quarter, FDA action is expected on the Biologics License Application (BLA) filed by ENHANZE partner Genentech, a member of the Roche Group, for the subcutaneous (SC) formulation of trastuzumab (Herceptin). In the second half of 2019, ENHANZE partner Janssen Biotech, Inc. anticipates filing for approval of the SC formulation of its multiple myeloma drug daratumumab (Darzalex). Also in the second half, Halozyme expects a phase 3 study will be initiated by a partner for an undisclosed target.

By the end of 2019, the company expects three ENHANZE programs to be in phase 3 studies and to have nine active phase 1 programs in addition to its three currently marketed products. This accelerating partner activity supports the projection of the potential for approximately $1 billion in royalty revenue in 2027. Additionally, potential lifetime milestone payments associated with existing ENHANZE partnership programs in development are projected to be $1 billion, with $225 million to $300 million in revenues projected between 2019 and 2021.

The company also provided an update on its late stage targeted oncology asset PEGPH20. Enrollment in HALO-301, the company’s phase 3 study evaluating PEGPH20 in metastatic pancreas cancer, was completed at the end of 2018 with approximately 500 subjects enrolled. The company projects the study will achieve its target of 330 OS (overall survival) events between August and November of 2019. Based on this timeline, the company projects topline results will be available in the second half of 2019.

Halozyme and its partners continue to explore the pan-tumor potential of PEGPH20. This includes ongoing phase 1b studies in pancreas cancer, gastric cancer, gall bladder cancer and cholangiocarcinoma.

2019 Financial Guidance

The company also provided financial guidance for 2019:

Net revenue of $175 million to $185 million, excluding revenue from any new ENHANZE global collaboration and licensing agreements.
Operating expenses of $265 million to $275 million, or $225 million to $235 million excluding an expected increase in cost of goods sold. Excluding the cost of goods sold the modest increase in expenses is driven by ENHANZE partner support, and support of the potential commercialization of PEGPH20.
Operating cash burn of $75 million to $85 million.
Debt repayment of approximately $90 million.
Year-end cash balance of $180 million to $190 million.
Table 1. 2019 Financial Guidance

Guidance Range

Net Revenue

$175 million to $185 million

Operating Expenses

$265 million to $275 million

Operating Expenses (excl. COGS)

$225 million to $235 million

Operating Cash Burn

$75 million to $85 million

Debt Repayment

~$90 million

Year-end Cash Balance

$180 million to $190 million

The company plans to report fourth quarter and full year 2018 financial results on February 21, 2019.

A replay of Dr. Torley’s presentation at the conference today can be accessed for the next 90 days via the "Investors" section of www.halozyme.com. Also, a copy of the presentation made today was filed with the Securities and Exchange Commission as part of a Form 8-K that can also be accessed via the "Investors" section of www.halozyme.com.

Veracyte to Present at the 21st Annual Needham Growth Conference

On January 9, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported that Bonnie H. Anderson, chairman and chief executive officer, is scheduled to present at the 21st Annual Needham Growth Conference in New York City on Tuesday, January 15, 2019 at 8:40 a.m. EST (5:40 a.m. PST) (Press release, Veracyte, JAN 9, 2019, View Source [SID1234532601]).

A live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.